Gallant™ CDVRA500Q

GUDID 05415067031990

Implantable Cardioverter Defibrillator

ST. JUDE MEDICAL, INC.

Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator Single-chamber implantable defibrillator

• Primary Device ID: 05415067031990
• NIH Device Record Key: 301aeab4-5eb2-41d3-a2b8-3d89ef5c4de6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gallant™
• Version Model Number: CDVRA500Q
• Catalog Number: CDVRA500Q
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067031990 [Primary]

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-10
• Device Publish Date: 2020-09-02

On-Brand Devices [Gallant™]

• 05415067032010: Cardiac Resynchronisation Therapy Defibrillator
• 05415067032003: Implantable Cardioverter Defibrillator
• 05415067031990: Implantable Cardioverter Defibrillator
• 05415067049520: HF Cardiac Resynchronization Therapy Defibrillator
• 05415067049476: DR Implantable Cardioverter Defibrillator
• 05415067049421: VR Implantable Cardioverter Defibrillator